To perform a human pilot study to prove the hypothesis that a hybrid transgastric cholecystectomy is a safe procedure.
ID
Source
Brief title
Condition
- Gastrointestinal conditions NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Safety of the procedure.
Secondary outcome
To evaluate postoperative pain, body imag and quality of life perception.
Background summary
Potential benefits of NOTES could be less incision related complications, such
as surgical site infection and hernia, and faster recovery of the patient with
less post-operative stress and pain. In our previous study we performed a
successful transgastric, hybrid cholecystectomy with uncomplicated gastric
closure in a porcine survival model.
Study objective
To perform a human pilot study to prove the hypothesis that a hybrid
transgastric cholecystectomy is a safe procedure.
Study design
Pilot study.
Intervention
Transgastric laparoscopic assisted cholecystectomy.
Study burden and risks
For this study we will perform a transgastric cholecystectomy with laparoscopic
assistance. In our previous porcine survival trial we performed a successful
procedure in all pigs. We expect to make less and smaller abdominal incisions
than needed for a conventional laparoscopic cholecystectomy. Benefits of this
less invasive approach could be less incision related complications, such as
surgical site infection and hernia. Additionally, faster recovery of the
patient with less post-operative stress and less pain could be achieved.
Because of less and minor incisions, patients can experience better cosmesis
than after a conventional laparoscopic cholecystectomy. potential risks
associated with the procedure could be a bleeding during creation of the
gastrotomy, unsuccessful closure of the gastrotomy or infection following the
procedure. In case of any complications during or following the procedure both
gastroenterologist and surgeon that perform the procedure will decide what
actions should be taken.
Meibergdreef 9
1105 AZ
NL
Meibergdreef 9
1105 AZ
NL
Listed location countries
Age
Inclusion criteria
- * 18 years
- Informed consent
- Uncomplicated symptomatic cholecystolithiasis, defined as gallbladder stones on abdominal ultrasound in combination with clinical signs such as recurrent pain attacks in the right upper abdominal region (biliary colic) associated with or without nausea and vomiting
- Gallbladder stones with a maximal diameter of 1 cm
Exclusion criteria
- Active cholangitis
- Choledocholithiasis
- Previous upper abdominal surgery
- Signs of cholecystitis in the past
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL35071.018.11 |